This article discusses the recent decreases in the FDA’s manufacturing inspections due to COVID-19 and explains how USP’s programs and resources can help drug-product manufacturers and ingredient suppliers manage potential quality risks in the global supply chain.

Ensuring excipient quality requires extra-monograph testing and specifications, which should be agreed upon between the excipient end user and supplier. This article discusses how application of Quality-by-Design (QbD) principles can help to define such extra-monograph testing and specifications.

The regulatory concept of Quality by Design is a gateway to improved cost control and faster, bigger returns on investment. This article discusses how pharmaceutical manufacturers can unlock these benefits by using a system that integrates their product development and regulatory sciences and submissions teams, focusing on quality at every step.

A blister pack inspection system must function properly to ensure the quality and accuracy of blister-packaged pharmaceutical tablets and capsules. This article explains how validation, periodic verification, and ongoing monitoring can keep an inspection system operating as intended and ensure that products are adequately and accurately inspected, while keeping accurate inspection records.

When outsourcing manufacturing for an oral solid dosage product, brand owners generally minimize risk by ensuring that the contract manufacturing organization’s (CMO’s) unit operations have the desired capability and have been tested with the target formulation and that the area has sufficient containment and environmental controls. They also typically confirm that the CMO’s site leadership team has a demonstrated commitment to quality, analytics, and regulatory compliance. An area of risk that is often overlooked, however, is powder transfer between unit operations.

This article discusses the importance of finding organic substitutes to traditional excipients and presents a study that used premixed natural excipients to incorporate an oily substance into a powder for encapsulation.

Earlier this year, proposed changes to the Nutrition and Supplement Facts panels started coming into mandatory compliance. This article discusses these changes to regulations governing dietary supplements, their impact on nutritional information and claims, and the possible ramifications of non-compliance.

This edition of Eye on Excipients discusses orodispersible minitablets as an alternative dosage form for pediatric patients and others who have difficulty swallowing traditional tablets. The column also describes a study conducted to determine the suitability of agglomerated isomalt as a filler-binder for direct-compression orodispersible minitablets with a low drug load.